Efficacy of vitamin A supplementation for prevention and severity reduction of hand-foot-mouth disease in young children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20191002003

Enrollment

4000

Registered

2019-10-02

Start date

2019-11-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand&#45

Interventions

Syrup with comparable compositions with the active drug except that there is no active drug,Vitamin A syrup 25&#44

000 U/2.5 mL

Placebo Comparator Drug,Active Comparator Drug

Placebo,Vitamin A

Eligibility

Sex/Gender

All

Age

1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Preschool children ages 1-6years attending participating childcare centers/kindergarten. 2. Parents or guardians consent to participate.

Exclusion criteria

Exclusion criteria: 1. Taking vitamin A supplementation within one month prior to enrollement. 2. Known to be HIV-infected. 3. Having had Hand Foot Mouth Disease within one month prior to enrollement

Design outcomes

Primary

Measure	Time frame
Incidence and severity of Hand Foot Mouth Disease 1 year Incidence	—

Secondary

Measure	Time frame
Size of outbreaks of HFMD in childcare centers/kindergartens in treatment versus control arms. 1 year Incidence of outbreak,Association of low serum vitamin A level and severity of HFMD in both arms 1 year Odds ratio	—

Countries

Thailand

Contacts

Public ContactNopporn Apiwattanakul

Ramathibodi Hospital Mahidol University

nopporn.api@mahidol.ac.th+66819295281

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Efficacy of vitamin A supplementation for prevention and severity reduction of hand&#45;foot&#45;mouth disease in young children